Advanced ER+, HER2-Negative Breast Cancer Clinical Trial
Official title:
A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of elacestrant (RAD1901) in patients with advanced ER+, HER2-negative breast cancer.
The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of elacestrant in patients with advanced ER+HER2-negative breast cancer. The secondary objectives of this study are: - To assess the safety and tolerability of elacestrant - To evaluate the pharmacokinetics (PK) of elacestrant - To evaluate the preliminary anti-tumor effect of elacestrant ;